Agile Search Inc. · 23 hours ago
Design Assurance Quality Engineer
Greater Boston
Full-time
Onsite
Mid, Senior Level
$125K/yr - $165K/yr
5+ years expAgile Search Inc. is an established and funded startup focused on enabling a cure for patients suffering from atrial fibrillation. The Design Assurance Engineer will support engineering and new product development activities for the Quality Assurance department in a dynamic environment.
Human Resources
No H1B
U.S. Citizen OnlyHiring Manager
John Compton
Responsibilities
Support new product development and product realization through design control phase activity including development, verification, validation, transfer, and associated design reviews for software/data science, hardware/systems, and catheter engineering
Support sustaining engineering through operational quality activity – material control, inspection/acceptance activity, nonconforming material control, equipment qualification, supplier management, CAPA, and clinical operations including handling and control of protected health information
Support software design, development, risk analysis, qualification, and version release activity and applicable documentation deliverables, including relevant cybersecurity considerations
Participate in risk management activity - analysis and documentation applied throughout the product development process
Inspect and test materials, equipment, processes, and products to ensure quality specifications are met
Support test method development and qualification activity
Support the design engineering teams for catheter, hardware, software and systems throughout the design control process
Design and implement quality system processes to comply with regulatory standards
Foster a culture of trust, open communication, and continuous improvement, with an unwavering focus on advancing patient outcomes
Qualification
Required
Degree in Mechanical, Biomedical Engineering or related applicable engineering field
Minimum of 5 years experience in product development, quality engineering or a related role in a regulated medical device product development
Experience in catheter, hardware, software and systems design and development, or with similar medical devices, while working within an early stage Quality Management System
Applied understanding of 21 CFR 820, ISO 13485:2016, ISO 14971:2019, IEC 60601-1:2020, IEC 62304:2006, GDPR, and HIPAA regulations
Demonstrated expertise in Process Validation, Product Validation, and Statistical Methods
Experience in risk management and design controls
Excellent communication skills, good documentation practices (formal protocols and reports), attention to detail, and project management skills
Company
Agile Search Inc.
The Agile Search mission is to help our partner companies build unstoppable teams.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
John Compton
Founder and President
Company data provided by crunchbase